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ORIA Top Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Top Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Top Clip System includes components made from commercially pure titanium and titanium alloy described by ASTM Standards F67 GR2 and ASTM F136, respectively. These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: pedicle screws, set screws, top locking clips and rods.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the ORIA Top Clip System, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. It describes the device, its intended use, materials, and states that substantial equivalence is based on fundamental scientific technology and indications/intended use.

Therefore, I cannot provide the requested table and information about a study from the given text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing equivalence, not specific performance metrics against defined acceptance criteria.
2. Sample sized used for the test set and the data provenance: No test set is mentioned, as no study demonstrating performance is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no "test set" or ground truth establishment study described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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